NDA 21751, held by Hameln Pharma Plus. Pentetate Zinc Trisodium.
As of Nov 14, 2026, NDA 21751 (Pentetate Zinc Trisodium), held by Hameln Pharma Plus, was first approved by FDA on Aug 11, 2004, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 11, 2004 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pentetate Zinc TrisodiumEQ 1GM BASE/5ML (EQ 200MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;inhalation, intravenous | Pentetate Zinc Trisodium | DiscontinuedReference drug |
| Mar 21, 2013 | Supplement 8Labeling · Standard review | Approved | |
| Aug 4, 2005 | Supplement 2Labeling · Standard review | Approved | |
| Aug 11, 2004 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
